Clinical trial · Interventional
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients With Advanced Solid Malignancies
NCT01895946CI-TRIAL-00022375OAKcompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancy, | — | UNRESOLVED | — |
| Pharmacokinetics, Pharmacodynamics, | — | UNRESOLVED | — |
| Safety and Tolerability, | — | UNRESOLVED | — |
| Tumour Response, | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD5363 | Drug | Capivasertib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Formulation Switch
- description
- AZD5363 tablet twice daily followed by AZD5363 capsule twice daily on an intermittent regimen (4 days on, 3 days off).
- interventionNames
- Drug: AZD5363
- type
- EXPERIMENTAL
- label
- Part B: Food effect
- description
- AZD5363 tablet twice daily on an intermittent regimen (4 days on, 3 days off) with/without food on one occasion
- interventionNames
- Drug: AZD5363
Primary outcomes (2)
- measure
- Ratio of Css,Max for Day 4 to Day 11
- timeFrame
- Day 4 and Day 11
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: - * Aged at least 18 years * The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist * The presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is suitable for repeated assessment * Estimated life expectancy of more than 12 weeks Exclusion Criteria: - * Clinically significant abnormalities of glucose metabolism * Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids) * Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and Human Immunodeficiency Virus (HIV) * Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures * A bad reaction to AZD5363 or any drugs similar to it in structure or class
References
Publications (0)
Data not yet available
No reference posted for this study.